dent: Haruo Naito) announced today that it is pleased to announce the release of Calcium Antagonistic Arrhythmia Treatment "Wasolan® Tablet 40 mg" and "Wasolan® IV 5 mg" (generic name: verapamil hydrochloride) , And obtained additional approval for pediatric indication for supraventricular tachyarrhythmia.
Arrhythmia in children is said to be one of the main causes of sudden death in childhood, as well as symptoms affecting daily life such as palpitation, dizziness, and shortness of breath. There are cases where it is difficult to treat with arrhythmia which has been approved in Japan until enough effect is obtained by a medicine for arrhythmia or it is difficult to treat with catheter depending on age and physique, and it is a problem to be solved in pediatric medicine .
This drug is positioned as a standard therapy for pediatric tachyarrhythmia in Europe and the United States, and the indication for children is approved. In Japan, on the other hand, there are few therapeutic agents approved for pediatric indications, and there are no therapeutic agents for which indication for children is approved for antiarrhythmic drugs having the same mechanism of action as this drug. As a result, with regard to pediatric indication for this drug, it was eva luated as highly applicable to publicly-known applications at medical consultation meeting "unconfirmed drug / non-applicable drug treatment review meeting" by the Ministry of Health, Labor and Welfare . In response to this, the Company had applied for the addition of dosage, dosage and dosage for children on November 16, 2010.
This drug suppresses tachycardia arrhythmias by suppressing calcium ion inflow into cells and delaying the excitatory conduction of the heart. In Japan, it is the first calcium antagonist to have indication for pediatric tachyarrhythmia.
Regarding pediatric indications in the cardiovascular field, we acquired additional approval of Tamborkol® tablet for the treatment of tachyarrhythmia in May 2010 and Warfarin tablets for oral anticoagulant in February 2011 . Together with this approved calcium antagonistic arrhythmia therapeutic agent "Wasolan® tablet 40 mg" and "Wasolan® intravenous injection 5 mg", we established appropriate medication therapy in pediatric medical care and made a further contribution to patients I will come.
that's all
[Approval summary as a reference material, Attached to the known application]
<Reference Material>
1. Outline of approval of "Wasolan® tablet 40 mg" (underlined part is the additional part of this time)
1) Indications and effects
Adults:
Tachyarrhythmia (atrial fibrillation / flutter, paroxysmal supraventricular tachycardia), angina pectoris, myocardial infarction (excluding acute phase), other ischemic heart diseases
Child:
Tachyarrhythmia (atrial fibrillation / flutter, paroxysmal supraventricular tachycardia)
2) Dosage and dose
Adults:
Tachyarrhythmia (atrial fibrillation / flutter, paroxysmal supraventricular tachycardia)
For adults, 1 to 2 tablets (40 to 80 mg once as verapamil hydrochloride) are administered orally three times a day. In addition, it should be reduced appropriately according to age and symptoms.
◯ Angina pectoris, myocardial infarction (except acute phase), other ischemic heart disease
For adults, 1 to 2 tablets (40 to 80 mg once as verapamil hydrochloride |
